The additional indication is for chhildren as young as 8 years of age with heterozygous familial hypercholesterolemia.
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GA Depot is a once-monthly injection to treat patients with relapsing forms of multiple sclerosis. No information was provided for why the FDA issued a complete response letter.
The submission is for the same indications, including Xolair’s recently approved indication IgE-mediated food allergy.
Michigan’s state Medicaid agency has signed an outcomes-based agreement for Lyfgenia patients with sickle cell disease. The agreement provides payers with risk sharing tied to vaso-occlusive events-related hospitalizations
It can now be used to reduce the risk of cardiovascular death, heart attack and stroke in overweight patients with heart disease.
Regulators want to discuss safety issues, as well as the phase 3 trial’s design where patients were treated based on an assessment of amyloid plaque and the inclusion of patients based on tau protein levels.
The new biosimilar, Tyenne, was approved in both an IV and a subcutaneous forms to treat inflammatory conditions such as arthritis.
Quantile Health is offering a new solution to help small health plans and self-insured employers fund gene therapy access — with a subscription model.
Both Wyost and Jubbonti are interchangeable for the reference products and are approved for all of the same indications
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The FLOW trial was stopped early based on an interim analysis that found the study met the criteria for efficacy.
Fran Gregory, Pharm.D., of Cardinal Health, talks about a survey of ophthalmologists and their concerns about using biosimilars for retinal conditions.
Rybrevant is indicated to be used in combination with chemotherapy as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer.
Beginning in 2025, people with Medicare Part D drug coverage will have the option to pay out-of-pocket costs in monthly payments spread out over the year.
Mercer has teamed up with Free Market Health to offer employers Mercer SelectRx, which searches a network of specialty pharmacies for the lowest price on specialty medications.
The target action date is Oct. 15, 2024, for full approval of Ocaliva to treat patients with primary biliary cholangitis. The FDA is planning to hold an advisory committee meeting to discuss the application.
iDose TR was approved to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. It has a wholesale acquisition cost of $13,950 per dose/implant.
The Prescription Drug User Fee Act action date is Aug. 28, 2024.
The FDA has set an action in December 2024 for tislelizumab — now with the brand name Tevimbra — for metastatic gastric or gastroesophageal junction cancers.
The FDA is reviewing Epkinly to treat relapsed or refractory follicular lymphoma. The target date is in August 2023.
Biktarvy can now be used to treat people with HIV who have a known or suspected M184V/I mutation, a common form of treatment resistance.
CarelonRx will provide digital coaching and wellness tools and incorporate behavioral and social health screenings for members.
At the moment, Simlandi (adalimumab-ryvk) has the high-concentration, citrate-free, interchangeable Humira (adalimumab) market to itself.
Regulators indicated that the confirmatory study did not confirm Pepaxto’s clinical benefit and that there was no evidence of safety or efficacy.
The economy and healthcare costs are the issues voters want to hear about going into the 2024 presidential election, finds a survey by KFF.
If approved, this would be the sixth indication for Dupixent and the only biologic therapy for COPD. The target action date is June 27, 2024.
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